Ligence Heart— 510(k) K253535

Name: FDA 510(k) clearance K253535
Creator: U.S. Food and Drug Administration
Published: 2026-02-27

Substantially Equivalent

Ligence Uab

FDA 510(k) clearance K253535 for Ligence Heart, Substantially Equivalent on 2026-02-27. Applicant: Ligence Uab. Device class: 2.

Summary

Ligence UAB's Ligence Heart is filed under product code QIH, automated radiological image processing software. Beyond the name and that code name, the record doesn't describe the software.

Class II, 21 CFR 892.2050. Radiology is both the classification panel and the review panel. It came in as a Traditional 510(k).

Ligence filed from Kaunas, Lithuania. Review took 106 calendar days (November 13, 2025 to February 27, 2026), ending in a substantially equivalent decision.

Clearance details

Applicant: Ligence Uab
Product code: Product code QIH
Device class: Class 2
Regulation: 21 CFR 892.2050
Advisory panel: Radiology
Date received: 2025-11-13
Decision date: 2026-02-27
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Kaunas, LT

Download summary PDF View on FDA.gov ↗

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K260055 — syngo.CT Brain Quantification2026-09-25

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K252105 — Ligence Heart2025-09-26

Data sourced from openFDA. This site is unofficial and independent of the FDA.